Dare Biosciences Inc. (NASDAQ: DARE) stock gains by 3.73% in the current market trading. Dare Bioscience is a clinical-stage pharmaceutical business dedicated to the development of novel women’s health products.
DARE Stock, Current Development
DARE’s New Drug Application (NDA) for DARE-BV1 for the cure of bacterial vaginosis has been approved for filing by the US Food and Drug Administration. The FDA approved this application Priority Evaluation and set a deadline of December 7, 2021, to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA). Applications for prospective medicines that after being granted, would make a substantial advance in the safety or efficacy of the treatment of a severe condition are given Priority Review by the FDA.
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Positive outcomes from the DARE-BVFREE Phase 3 randomized study assessing DARE-BV1 in women with bacterial vaginosis support the NDA. It’s a disease that can have significant health consequences and produce a slew of unpleasant symptoms, and it’s thought to afflict about 21 million women in the United States. DARE-BV1 is a research-stage thermosetting bioadhesive hydrogel containing 2% clindamycin phosphate that is intended to be used as a one-time vaginally given therapy for bacterial vaginosis.
The FDA has given DARE-BV1 the classifications of Qualified Infectious Disease Product (QIDP) and Fast Track for the cure of bacterial vaginosis. If authorized, DARE-BV1 will obtain an extra five years of market exclusivity under the QIDP designation, in addition to the three years allowed for having created new clinical evidence.
Parallel to the regulatory procedure, ongoing strategic talks and other efforts are undertaken to enable a successful commercial debut of DARE-BV1 in 2022, if permitted. Dare’s intention to complete and publish the marketing strategy for DARE-BV1 in the United States coincides with the FDA’s anticipated date for completion of its evaluation of December 7, 2021.
DARE-BV1 might be commercialized in a variety of ways, including:
- Granting pharmaceutical firms with other commercial products in women’s health and out-license to solely sell DARE-BV1.
- If approved, sell and distribute the goods in defined geographic areas.
- Using commercial sales organizations and other commercial operations for market access, marketing, distribution, and other relevant services.
- Putting together a mix of various possible choices to co-promote the goods.